The products we use are regulated by the FDA as a human tissue-based product under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. These products are only allowed to be used by licensed health care practitioners.
Our products are processed from structural Wharton’s jelly, amniotic fluid and membrane collected with donors with normal full-term pregnancies. Each donor is carefully screened. Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493. Each donor is tested for HBsAG (Hepatitis B Surface Antigen), HBcAb (Hepatitis B core Antibody), HCV (Hepatitis C Antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and 2), Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test). Products are tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens and is non-pyrogenic.
Setting standards: from donor to doctor to patient.
FDA announces comprehensive regenerative medicine policy framework.
U.S. Food and Drug Administration